New Full Sense Device to Combat Obesity
April 9, 2015"The initial concept for the Full Sense device came in 2004. I came up with the idea as another way to help people who are struggling with their own obesity. Since then my partners, Drs. Foote, Kemmeter, Walburn, and I have been working hard to take the concept through initial prototypes all the way to satisfy the requirements for eventual regulatory approval. The question I'm commonly asked is "Can the Full Sense Device help me?" The purpose of this article is to begin to answer that question."
~ Randal Baker, M.D., F.A.C.S.
Full Sense Device and Obesity
First, I'd like to give you some of my behind-the-scenes thoughts on The Full Sense device and how it might impact the obesity scene. We all recognize there is an extreme obesity epidemic in our country and around the globe. Unfortunately, the current approaches are not making a significant impact on overall obesity trends.
I am, and have always been, a strong proponent of bariatric surgery. We have excellent bariatric surgeons and centers in our country along with great support organizations such as ObesityHelp.com. That notwithstanding, we need more tools in our arsenal to combat obesity. This is not a time to consider an “either/or” strategy but rather a “both/and” approach. Bariatric surgery is helping less than 1% of eligible patients.
Bariatric Options as "Food Based"
The present bariatric options are largely what I call “food based.” Food enters the small pouch or sleeve and causes the satiety and other such hormonal changes. This approach is also an Achilles heel of the present paradigm. Our group at Grand Health Partners has performed over 9,000 bariatric surgical procedures and has to spend much time before and after surgery discussing proper eating techniques to optimize weight loss associated with surgery. Some refer to this as “pouch tool techniques,” a phrase largely borrowed from RYGB surgery.
The three most common mistakes in the food based scenario that undermine weight loss are:
1. drinking too much liquid with the meal,
2. drinking liquids with calories, and
3. grazing throughout the day.
Liquids wash out the food from the pouch and allow more food to be consumed. Liquids with calories slide through with little metabolic/satiety impact but bring calories. Grazing allows more consumption of small but collectively significant amounts that lead to less immediate satiety feedback but more calories over time.
How the Full Sense Device Works
The Full Sense, I believe, is truly different because it engages the neuro-humeral network in a non-food dependent fashion. Patients are less hungry yet more full even without food. The device puts pressure on the top of the stomach to trigger signals and hormones that cause weight loss. Patients eat less but also do not enter the "stress starvation state" that is often seen with diets and significant calorie deprivation. Our studies seem to indicate that a patient's energy expenditure remains elevated even with less intake with the Full Sense in place. Fluid intake, grazing, and liquids with calories do not seem to have a significant impact on the Full Sense weight loss.
It also takes about 10 minutes or so to place the device and requires no incisions. The cost will be significantly less than current approaches, and within the range that many can pay out-of-pocket. The device likely has great potential for children and adolescents who are early in the obesity spectrum. All of these attributes, I believe, are necessary for us to be able to begin to impact this epidemic. We need non-invasive, less expensive tools with significant effects.
My replies to "just shut your mouth" & "weight regain"
I would like to address a few preliminary questions that I received after the Buzzfeed article appeared online, there were a couple of comments that I'll provide my reply to:
"We don't need this invention, we already have one - just shut your mouth!"
If that invention already exists, it certainly doesn't seem to be working out very well. Good scientific studies have clearly shown obesity is more than just a lack of willpower. Many factors including genetics are directly involved. If we ignore this science and just tell people to "shut their mouths" we will be here in a few more years with even more overweight and obese people. This "head in the sand" approach will lead to a greater obesity epidemic. In fact, studies of identical twins raised in different environments have shown a much greater relationship to genetics than environment. The cause of obesity is multi-factorial and likely will be the cure.
"Won't patients just regain their weight if the device is removed?"
The answer is that some may, but many will not. Ultimately, that is the patient's prerogative. We have seen that patients who lose a higher percentage of their weight or who are early in the obesity disease progress will likely have less regain. We have many female patients in our practice who gain weight in the peri-pregnancy period but who could sustain weight loss after pregnancy if they were able to return to normal weight. Many older people struggle with weight loss because they have bad joints and need replacements to become more active. A less invasive weight loss strategy would benefit them greatly.
The first generation of Full Sense will be temporary because as long as the device is in place, patients continue to lose weight. To make the device last longer, an adjustability component must be present to decrease the pressure as the patient gets closer to ideal weight. We believe an approach utilizing a multidisciplinary bariatric center with dietitians, behaviorists and exercise specialists is important to optimize and sustain the weight loss potential of the technology. Further, it is also much easier to embrace the necessary behavioral changes (such as exercise) with a normal weight than with extra pounds. Many patients desire a chance to just start over. Fortunately, the temporary device can usually be placed again if needed after maximal efforts.
The Full Sense device has undergone significant in-vitro and in-vivo testing, and is on the path to obtain regulatory approval as an option for persons that desire a way to combat their own obesity.
Check out Part 2, Question and Answers from our interview with Dr. Baker!
Photo credit: Dr. Randal Baker
 | ABOUT THE AUTHOR Randal Baker, M.D., F.A.C.S. is a native of Grand Rapids, Michigan. He graduated from South Christian High School and then received his B.A. from Calvin College. He earned his M.D. from Albany Medical College of New York. He is an Assistant Professor of Surgery for Michigan State College of Human Medicine and currently serves as the Medical Director of Bariatrics for McLaren Northern Michigan Regional Hospital.Read more articles from Dr. Randal Baker! |
